The U.S. Food and Drug Administration (FDA) has approved Onapgo, a groundbreaking wearable infusion device designed to aid those with advanced Parkinson’s disease. This small, lightweight device administers apomorphine directly into the bloodstream, providing a continuous dose under the skin. The approval comes after promising results from a clinical trial involving 107 participants, positioning Onapgo as a pivotal development in managing movement issues and daily symptom fluctuations in Parkinson’s patients.
Parkinson's disease, affecting approximately 1 million Americans and over 10 million individuals worldwide, is characterized by its progressive nature and symptoms that vary throughout the day. Patients often experience uncontrollable movements known as dyskinesia, making everyday tasks challenging. Onapgo's ability to deliver a steady apomorphine dose aims to enhance mobility, reducing "off" times by 2.6 hours and increasing "on" times by 2.8 hours after just 12 weeks of use.
Comparatively, Onapgo outperformed placebo treatments, offering an additional 1.7 hours of increased "on" time and decreased "off" time. Participants using Onapgo also reported an improvement in their overall well-being, further underscoring the device's potential to transform daily life for those grappling with advanced Parkinson's disease.
Though the device provides a promising treatment option, it is essential for patients to consult their healthcare providers before commencing therapy. Discussions should include medical history considerations, particularly for individuals with conditions such as daytime sleepiness, dizziness, heart issues, high or low blood pressure, stroke history, breathing problems, kidney or liver concerns, mental health conditions, or those who are pregnant or breastfeeding.
In addition, patients must adhere to guidelines that prohibit intravenous injection of Onapgo, as this can lead to blood clots and other severe complications. The device is designed exclusively for subcutaneous use to ensure safety and efficacy.
Onapgo is set to become available in the second quarter of 2025, offering new hope for adults with advanced Parkinson's disease. With its FDA approval, the device marks a significant stride in managing movement disorders associated with the condition.
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